A Dose Escalation Study Evaluating CPI-818 in Relapsed/Refractory T-Cell Lymphoma

Trial ID or NCT#

NCT03952078

Status

not recruiting iconNOT RECRUITING

Purpose

This is a Phase 1/1b, open-label, first in human study of CPI-818, an oral interleukin-2-inducible tyrosine kinase (ITK) inhibitor for the treatment of relapsed/refractory (R/R) T-cell lymphoma.. This trial will study the safety, tolerability, and anti-tumor activity of CPI-818 as a single drug.

Official Title

A Phase 1/1b Dose-Escalation Trial Evaluating CPI-818, an Oral Interleukin-2-Inducible T-Cell Kinase Inhibitor, in Subjects With Relapsed/Refractory T-Cell Lymphoma

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * Adult subjects age ≥18 years* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1* Histologically confirmed evidence of T-cell lymphoma* Measurable disease.* Adequate organ function.* At least 2 standard therapies for advanced or recurrent disease or had a disease for which there is no more than one established therapy.
Exclusion Criteria:
  1. * Treatment with systemic immunosuppressive medication.* History of allogeneic hematopoietic stem cell transplantation.* History of primary immunodeficiency, solid organ transplantation.* History of opportunistic infection within 180 days of starting study drug.* Females who are pregnant, lactating, or intend to become pregnant* History of invasive prior malignancy that required systemic therapy within last 3 years.* Concomitant use of strong inhibitors or inducers of CYP3A.
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Investigator(s)

Youn H Kim, MD
Youn H Kim, MD
Dermatologic oncologist, Cutaneous oncology specialist, Dermatologist
The Joanne and Peter Haas, Jr., Professor for Cutaneous Lymphoma Research and Professor, by courtesy, of Medicine (Oncology)

Contact us to find out if this trial is right for you.

Contact

Elle Kim
650-387-4436

View on ClinicalTrials.gov